Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

cDC1 Prognostic and Predictive Role in Non-Small-Cell Lung Cancer Patients Receiving Immune Checkpoint Inhibitors (LUNG-PREDICT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069442
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
The response rate of immune checkpoint inhibitors remains relatively low and the identification of the new predictive biomarkers is necessary. The rare population of cDC1 is very interesting, as its mouse counterparts is essential for the cross presentation of tumor-associated antigens, tumor immunity and response to immunotherapies. Their role in humans has not been studied. This proposal aims to study the prognostic role of cDC1 in a cohort of patients with advanced NSCLC, possibly demonstrating their positive predictive value of immune checkpoint inhibitors response.

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Other: This is a non-interventional study

Detailed Description:

Multicenter study aiming to collect patient's clinical data retrospectively and their histological samples prospectively.

The cohort will include:

  • 30 patients PD-L1 > 50% treated with pembrolizumab in first line and having a progression free survival ≥ 3 months
  • 30 patients PD-L1 > 50% treated with pembrolizumab in first line and having a progression free survival < 3 months
  • 30 patients PD-L1 < 50% treated with cisplatin-based chemotherapy in first line

Layout table for study information
Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: cDC1 Prognostic and Predictive Role in Non-Small-Cell Lung Cancer Patients Receiving Immune Checkpoint Inhibitors
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
cDC-1 positive
cDC-1 positive patients according to RNAseq and in situ analysis
Other: This is a non-interventional study
This is a non-interventional study

cDC-1 negative
cDC-1 negative patients according to RNAseq and in situ analysis
Other: This is a non-interventional study
This is a non-interventional study




Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 1 year ]
    To validate the cDC1 infiltration as predictive biomarker of pembrolizumab response


Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 1 year ]
    To compare the overall response rate (ORR) of cDC1-positive patients to cDC1 negative ones within those treated with pembrolizumab and on the entire cohort

  2. Time to treatment failure (TTF) [ Time Frame: 1 year ]
    To compare the time of treatment failure (TTF) on CDC1-positive patients to negatives ones within those treated with pembrolizumaband on the entire cohort


Other Outcome Measures:
  1. Overall survival (OS) [ Time Frame: 1 year ]
    To compare the overall survival (OS) of cDC1-positives patients to negatives ones within those treated with pembrolozumab and on the entire cohort



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Retrospective cohort of pembrolizumab or cisplatin-based chemiotherapy treated patients performing these regimens in first-line according to their PD-L1 score
Criteria

Inclusion Criteria:

  • NSCLC diagnosis
  • Advanced disease (Stage III-IV) according to the TNM 7th/8th classification
  • Patients have to have performed pembrolizumab in first line if PD-L1 ≥ 50% or cisplastin-based chemotherapy if PD-L1 < 50%
  • FFPE material available from diagnostic sample

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069442


Contacts
Layout table for location contacts
Contact: Elisa GOBBINI +33(0)476767575 EGobbini@chu-grenoble.fr

Locations
Layout table for location information
France
CHU Grenoble-Alpes
Grenoble, Isère, France, 38043
Contact: Elisa GOBBINI    +33(0)476767575    EGobbini@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Layout table for investigator information
Principal Investigator: Elisa GOBBINI CHU Grenoble-Alpes
Layout table for additonal information
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04069442    
Other Study ID Numbers: 38RC19.100
2019-A00959-48 ( Other Identifier: ID RCB )
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms